Overview

This trial is active, not recruiting.

Condition morbid obesity
Treatments ketamine, fentanyl
Phase phase 3
Sponsor University of Padova
Start date June 2012
End date June 2014
Trial size 90 participants
Trial identifier NCT01724983, KET2271

Summary

Ketamine may improve recovery from bariatric surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
patients will receive ketamine at induction
ketamine
(Active Comparator)
patients will receive fentanyl at induction
fentanyl

Primary Outcomes

Measure
pain level
time frame: postoperatively, up to 3 months
mood level
time frame: postoperatively, up to 3 months

Secondary Outcomes

Measure
total dosages of analgesic and muscle relaxant drugs
time frame: postoperatively, up to 3 months
postanesthetic recovery
time frame: postoperatively, up to 24 hours
satisfaction of the patient and of the surgeon
time frame: day 1
pulse oximetry saturation
time frame: postoperatively, up to 24 hours
lung volumes
time frame: postoperatively, up to 48 hours from end of surgery
antihemetic drug dosage
time frame: postoperatively, up to 24 hours
vasoactive drugs
time frame: intraoperatively and up to 24 hours from surgery end

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - age > 18 - obesity (Body Mass Index > 30) - ASA classificazion < 4 - candidate to bariatric surgery Exclusion Criteria: - known or presumed pregnancy - previous surgery on the airway, esophagus or stomach - uncontrolled psychiatric symptomatology

Additional Information

Official title Effects of Ketamine on Recovery From Bariatric Surgery
Principal investigator Ulderico Freo, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by University of Padova.